For Patients

Dysport for Injection (abobotulinumtoxinA), also called botulinum toxin type A, is made from the bacteria that causes botulism and is used to treat cervical dystonia (severe spasms in the neck muscles). It is also used to temporarily lessen the appearance of facial wrinkles. Common side effects include muscle weakness near where the medicine was injected; bruising, bleeding, pain, redness, or swelling where the injection was given; headache, muscle pain or stiffness, neck or back pain, fever, cough, sore throat, runny nose, flu symptoms, dizziness, drowsiness, tired feeling, nausea, diarrhea, stomach pain, loss of appetite, dry mouth, dry eyes, ringing in your ears, increased sweating in areas other than the underarms, itchy or watery eyes, increased sensitivity to light, or eyelid swelling or bruising.

The recommended initial dose of Dysport for the treatment of cervical dystonia is 500 Units given intramuscularly as a divided dose among affected muscles. The dose of Dysport for the treatment of glabellar lines (the vertical lines between the eyebrows) is 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect. Dysport may interact with cold or allergy medicines, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, irritable bowel medicines, or injected antibiotics. Tell your doctor all medications and supplements you use. During pregnancy, Dysport should be used only if prescribed. It is unknown if Dysport passes into breast milk. Consult your doctor before breastfeeding.

Our Dysport for Injection (abobotulinumtoxinA) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Dysport can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

trouble breathing, talking, or swallowing;

hoarse voice, drooping eyelids;

problems with vision;

unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

loss of bladder control;

crusting or drainage from your eyes;

severe skin rash or itching;

fast, slow, or uneven heartbeats; or

chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

muscle weakness near where the medicine was injected;

bruising, bleeding, pain, redness, or swelling where the injection was given;

headache, muscle pain or stiffness, neck or back pain;

fever, cough, sore throat, runny nose, flu symptoms,

dizziness, drowsiness, tired feeling;

nausea, diarrhea, stomach pain, loss of appetite;

dry mouth, dry eyes, ringing in your ears;

increased sweating in areas other than the underarms;

itchy or watery eyes, increased sensitivity to light; or

eyelid swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Clinical Studies Experience

Because clinical trials are
conducted under widely varying conditions, the adverse reaction rates observed
cannot be directly compared to rates in other trials and may not reflect the
rates observed in clinical practice. The adverse reaction information from
clinical trials does, however, provide a basis for identifying the adverse
events that appear to be related to drug use and for approximating incidence
rates.

Cervical Dystonia

The data described below reflect
exposure to Dysport in 357 cervical dystonia patients in 6 studies. Of these,
two studies were randomized, double-blind, single treatment, placebo controlled
studies with subsequent optional open label treatment in which dose
optimization (250 to 1000 Units per treatment) over the course of 5 treatment
cycles was allowed.

The population was almost entirely
Caucasian (99.2%) with a median age of 51 years (range 18-82 years). Most
patients (86.6%) were less than 65 years of age; 58.4% were women.

Common Adverse Events

The most commonly reported adverse
events (occurring in more than 5% of patients who received 500 Units of Dysport
in the placebo controlled clinical trials) in cervical dystonia patients were
muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue,
headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and
eye disorders (consisting of blurred vision, diplopia, and reduced visual
acuity and accommodation). Most adverse events were reported as mild or
moderate in severity. Other than injection site reactions, most adverse events
became noticeable about one week after treatment and lasted several weeks.

Dose-response relationships for
common adverse events in a randomized multiple fixed-dose study in which the
total dose was divided between two muscles (the sternocleidomastoid and
splenius capitis) are shown in Table 2.

Table 2: Common TEAEs by Dose
in Fixed-dose Study

System Organ Class
Preferred Term

Dysport Dose

Placebo

250 Units

500 Units

1000 Units

Any Adverse Event

30%

37%

65%

83%

Dysphagia

5%

21%

29%

39%

Dry Mouth

10%

21%

18%

39%

Muscular Weakness

0%

11%

12%

56%

Injection Site Discomfort

10%

5%

18%

22%

Dysphonia

0%

0%

18%

28%

Facial Paresis

0%

5%

0%

11%

Eye Disorders

0%

0%

6%

17%

Injection Site Reactions

Injection site discomfort and
injection site pain were common adverse events following Dysport
administration. These events were mainly of mild or moderate intensity.

Less Common Adverse Events

The following selected adverse
events were reported less frequently ( < 5%).

Breathing Difficulties

Breathing difficulties were
reported by approximately 3% of patients following Dysport administration and
in 1% of placebo patients in clinical trials during the double-blind phase.
These consisted mainly of dyspnea and were generally mild in intensity. The
median time to onset from last dose of Dysport was approximately one week, and
the median duration was approximately three weeks.

Other selected adverse events with
incidences of less than 5% in the Dysport 500 Units group in the double-blind
phase of clinical trials included dizziness in 3.5% of Dysport-treated subjects
and 1% of placebo-treated subjects, and muscle atrophy in 1% of Dysport-treated
subjects and in none of the placebo-treated subjects.

Laboratory Findings

Subjects treated with Dysport
exhibited a small increase from baseline (0.23 mol/L) in mean blood glucose
relative to placebo-treated subjects. This was not clinically significant among
subjects in the development program but could be a factor in patients whose
diabetes is difficult to control.

Electrocardiographic Findings

ECG measurements were only
recorded in a limited number of subjects in an open-label study without a
placebo or active control. This study showed a statistically significant
reduction in heart rate compared to baseline, averaging about three beats per
minute, observed thirty minutes after injection.

Glabellar Lines

Because clinical trials are
conducted under widely varying conditions, adverse reaction rates observed in
the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not be predictive of rates observed in
practice.

Table 3 reflects exposure to
Dysport in 398 subjects aged 19 to 75 who were evaluated in the randomized,
placebo-controlled clinical studies that assessed the use of Dysport for the
temporary improvement in the appearance of glabellar lines [see Clinical Studies].
Adverse events of any cause were reported for 48% of the Dysport-treated
subjects and 33% of the placebo-treated subjects. Treatment-emergent adverse
events were generally mild to moderate in severity.

Table 3: Treatment-emergent
Adverse Events with > 1% incidence

Adverse Events by Body System

Dysport
n=398
(%)*

Placebo
n=496
(%)*

Any Treatment-emergent

Adverse Event

191 (48)

163 (33)

Eye Disorders

Eyelid Edema

8 (2)

0

Eyelid Ptosis

6 (2)

1 ( < 1)

Gastrointestinal Disorders

Nausea

6 (2)

5 (1)

General Disorders and Administration Site Conditions

Injection Site Pain

11 (3)

8 (2)

Injection Site Reaction

12 (3)

2 ( < 1)

Infections and Infestations

Nasopharyngitis

38 (10)

21 (4)

Upper Respiratory Tract Infection

12 (3)

9 (2)

Sinusitis

8 (2)

6 (1)

Investigations

Blood Urine Present

6 (2)

1 ( < 1)

Nervous System Disorders

Headache

37 (9)

23 (5)

* Subjects who received treatment with placebo and Dysport
are counted in both treatment columns.

In the overall safety database, where some subjects received
up to twelve treatments with Dysport, adverse events were reported for 57%
(1425/2491) of subjects. The most frequently reported of these adverse events
were headache, nasopharyngitis, injection site pain, sinusitis, URI, injection
site bruising, and injection site reaction (numbness, discomfort, erythema,
tenderness, tingling, itching, stinging, warmth, irritation, tightness,
swelling).

Adverse events that emerged after repeated injections in
2-3% of the population included bronchitis, influenza, pharyngolaryngeal pain, cough, contact dermatitis, injection site swelling, and injection site
discomfort.

The incidence of eyelid ptosis did not increase in the
long-term safety studies with multiple re-treatments at intervals ≥ three
months. The majority of eyelid ptosis events were mild to moderate in severity
and resolved over several weeks. [see Injection Technique].

Post-marketing Spontaneous Reports

There is extensive post-marketing experience outside the
U.S. for the treatment of glabellar lines. Adverse reactions are reported
voluntarily from a population of uncertain size; thus, it is not always
possible to estimate their frequency reliably or to establish a causal
relationship to drug exposure. The following adverse reactions have been
identified during post-marketing use: vertigo, eyelid ptosis, diplopia, vision
blurred, photophobia, dysphagia, nausea, injection site reaction, malaise,
influenza-like illness, hypersensitivity, sinusitis, amyotrophy, burning
sensation, facial paresis, dizziness, headache, hypoesthesia, erythema, and
excessive granulation tissue.

Immunogenicity

As with all therapeutic proteins, there is a potential for
immunogenicity.

The incidence of antibody formation is highly dependent on
the sensitivity and specificity of the assay. In addition, the observed
incidence of antibody positivity in an assay may be influenced by several
factors including assay methodology, sample handling, timing of sample
collection, concomitant medications, and underlying disease. For these reasons,
comparison of the incidence of antibodies across products in this class may be
misleading.

Cervical Dystonia

About 3% of subjects developed antibodies (binding or
neutralizing) over time with Dysport treatment. The significance of these
antibodies is unknown since in the presence of binding and neutralizing
antibodies some patients may continue to experience clinical benefit.

Glabellar Lines

Testing for antibodies to Dysport was performed for 1554
subjects who had up to nine cycles of treatment. Two subjects (0.13%) tested
positive for binding antibodies at baseline. Three additional subjects tested
positive for binding antibodies after receiving Dysport treatment. None of the
subjects tested positive for neutralizing antibodies.